MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTÉGÉ MRI IPG; SCS IPG

Model Number 3771

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Staphylococcus Aureus (2058); Skin Irritation (2076); Post Operative Wound Infection (2446)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint of infection could not be confirmed via laboratory testing.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Event Description

Device 1 of 2.Reference mfr report#1627487-2015-09080.It was reported the patient experienced redness and skin irritation at the ipg site after using a heating pad over the site.Reportedly, the physician prescribed oral antibiotics as a precaution.Follow-up identified surgical intervention was undertaken on (b)(6) 2015.The scs system was explanted during the procedure due to staphylococcus aureus infection discovered in the ipg pocket which traveled up toward the lead.Moreover, the patient will receive further treatment through a picc line for an extended period of time as well as subsequent follow-up with an infectious disease physician.

• Brand Name: PROTÉGÉ MRI IPG
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: melissa nkematu ; 6901 preston road; plano, TX 75024 ; 9723092520
• MDR Report Key: 5300053
• MDR Text Key: 33582869
• Report Number: 1627487-2015-09079
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 3771
• Device Lot Number: 5182761
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR